A Study on the Effect of Food Containing Plant Extract on LDL-cholesterol Levels

Region

Japan

Condition

Condition

No

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Objectives

Narrative objectives1

To assess the efficacy of food containing plant extract on LDL-cholesterol levels

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

LDL-cholesterol

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Foods containing plant extract, 12 weeks consumption

Interventions/Control_2

Foods not containing plant extract, 12 weeks consumption

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Healthy males and females aged 20 to 64 years-old.
(2) Subjects whose BMI are 18.5 or over and under 30.
(3) Subjects whose LDL-cholesterol levels are under 140 mg/dL.
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

(1) Subjects who habitually use medications.
(2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) affecting obesity, hyperlipidemia, lipid metabolism, and so on during test periods.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease).
(5) Subjects who have declared allergic reaction to ingredients of test foods.
(6) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(7) Subjects who are shiftworker and/or midnight-shift worker.
(8) Subjects who have been diagnosed as familial hyperlipidemia.
(9) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating.
(10) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(11) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.